Device product
NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77352
Z-1678-2021
Product summary
- Event
- Event 87848
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 units
- Official record key
device-enforcement:Z-1678-2021
Official wording
Reason: Not manufactured to specification
Code information: Serial Numbers: 173939852, 173940027, 173940107, 173940346, 173940844, 173940852, 173942662
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada, Italy, Sweden, Switzerland.
Derived failure modes
-
Unknown
Not manufactured to specification